Apexigen Wins Orphan Drug Status for Esophageal and Pancreatic Cancer Treatment
The FDA has granted Apexigen an Orphan Drug designation for APX005M, an investigational treatment for esophageal and pancreatic cancer.
The company is currently evaluating the solid tumor treatment in several phase 2 studies for various cancers in combination with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine.
The FDA defines orphan drugs as those for conditions afflicting fewer than 200,000 individuals in the U.S. The Orphan Drug designation gives the company seven years of marketing exclusivity for its product, if approved.